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European Archives of Paediatric Dentistry Guidelines on the use of fluoride for caries prevention in children: An updated EAPD policy document --Manuscript Draft-- Manuscript Number: EAPD-D-19-00112 Full Title: Guidelines on the use of fluoride for caries prevention in children: An updated EAPD policy document Article Type: Invited Review Funding Information: Procter & Gamble Dr. Jack Toumba Abstract: SUMMARY The EAPD strongly endorses the daily use of fluoride as a major part of any comprehensive programme for the prevention and control of dental caries in children. Regardless of the type of programme, community or individually based, the use of fluoride must be balanced between the estimation of caries-risk and the possible risks of adverse effects of the fluorides. Fluoride use is considered safe when the manufacturer’s instructions are followed. Preventive programmes should be re- evaluated at regular intervals and adapted to a patient’s or population’s needs and risks. For the majority of European Countries, the EAPD recommends the appropriate use of fluoride toothpaste in conjunction with good oral hygiene to be the basic fluoride regimen. Key words: Fluoride, Caries, Child Corresponding Author: Jack Toumba Leeds Dental Institute Leeds, UNITED KINGDOM Corresponding Author Secondary Information: Corresponding Author's Institution: Leeds Dental Institute Corresponding Author's Secondary Institution: First Author: Jack Toumba First Author Secondary Information: Order of Authors: Jack Toumba Order of Authors Secondary Information: Author Comments: Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation
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Page 1: European Archives of Paediatric Dentistry · also been shown that early exposure to fluoride toothpaste might also be a risk factor due to unintended ingestion of toothpaste (Levy

European Archives of Paediatric Dentistry

Guidelines on the use of fluoride for caries prevention in children: An updated EAPDpolicy document--Manuscript Draft--

Manuscript Number: EAPD-D-19-00112

Full Title: Guidelines on the use of fluoride for caries prevention in children: An updated EAPDpolicy document

Article Type: Invited Review

Funding Information: Procter & Gamble Dr. Jack Toumba

Abstract: SUMMARYThe EAPD strongly endorses the daily use of fluoride as a major part of anycomprehensive programme for the prevention and control of dental caries in children.Regardless of the type of programme, community or individually based, the use offluoride must be balanced between the estimation of caries-risk and the possible risksof adverse effects of the fluorides. Fluoride use is considered safe when themanufacturer’s instructions are followed. Preventive programmes should be re-evaluated at regular intervals and adapted to a patient’s or population’s needs andrisks. For the majority of European Countries, the EAPD recommends the appropriateuse of fluoride toothpaste in conjunction with good oral hygiene to be the basic fluorideregimen.Key words: Fluoride, Caries, Child

Corresponding Author: Jack ToumbaLeeds Dental InstituteLeeds, UNITED KINGDOM

Corresponding Author SecondaryInformation:

Corresponding Author's Institution: Leeds Dental Institute

Corresponding Author's SecondaryInstitution:

First Author: Jack Toumba

First Author Secondary Information:

Order of Authors: Jack Toumba

Order of Authors Secondary Information:

Author Comments:

Powered by Editorial Manager® and ProduXion Manager® from Aries Systems Corporation

Page 2: European Archives of Paediatric Dentistry · also been shown that early exposure to fluoride toothpaste might also be a risk factor due to unintended ingestion of toothpaste (Levy

Guidelines on the use of fluoride for caries prevention in children: An updated

EAPD policy document.

Toumba KJ1, Twetman S2, Splieth C3, Parnell C4, van Loveren C5, Lygidakis NΑ6.

1Developmental & Preventive Sciences, Kuwait University, Kuwait.

2Department of Odontology, Faculty of Health and Medical Sciences, University of Copenhagen,

Denmark.

3Department of Preventive and Paediatric Dentistry, University of Greifswald, Germany.

4Oral Health Services Research Centre and HSE, Meath, Ireland.

5Department of Cariology, Academic Centre for Dentistry (ACTA), University of Amsterdam, The

Netherlands.

6Private Paediatric Dental Clinic, 2 Papadiamantopoulou Street, Athens 11528, Greece.

Corresponding author:

Professor Jack Toumba,

Developmental & Preventive Sciences,

Faculty of Dentistry,

Kuwait University,

Kuwait.

E-mail: [email protected]

Title Page

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Guidelines on the use of fluoride for caries prevention in children: An updated EAPD policy

document.

SUMMARY

The EAPD strongly endorses the daily use of fluoride as a major part of any comprehensive programme for

the prevention and control of dental caries in children. Regardless of the type of programme, community or

individually based, the use of fluoride must be balanced between the estimation of caries-risk and the

possible risks of adverse effects of the fluorides. Fluoride use is considered safe when the manufacturer’s

instructions are followed. Preventive programmes should be re-evaluated at regular intervals and adapted

to a patient’s or population’s needs and risks. For the majority of European Countries, the EAPD recommends

the appropriate use of fluoride toothpaste in conjunction with good oral hygiene to be the basic fluoride

regimen.

Key words: Fluoride, Caries, Child

1. Background considerations

The European Academy of Paediatric Dentistry (EAPD), in collaboration with the Hellenic Division of EAPD,

organised a workshop in Athens, Greece (June 1997), aimed at drawing up guidelines for future use of

fluorides among European children. The first draft of these guidelines was published in the EAPD newsletter,

and members were invited to make comments and suggestions. The revised first draft was then presented

at the biannual EAPD Congress in Sardinia (1998), where it was discussed in great detail, so that the

members' viewpoints were taken into consideration. The major concepts of the proposed guidelines were

approved, and a working group, consisting of the authors of the original paper, were authorised to finalise

and publish the recommendations (Oulis et al., 2000). In November 2008 the EAPD organised another

workshop, again in Athens, Greece, to update the original fluoride guidelines. These updated fluoride

guidelines employed the evidence-based SIGN (Scottish Intercollegiate Guidelines Network) methodology

Blinded Manuscript Click here to view linked References

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for ranking the levels of evidence and the grades of recommendations (SIGN 83, 2005; SIGN 50, 2008). In

November 2018 the EAPD organised another workshop, once again in Athens, Greece, to update the fluoride

guidelines. These updated fluoride guidelines employed the GRADE system (Ryan and Hill, 2016) to assess

the quality of evidence for the caries-preventive effect of various topical and systemic fluoride agents. The

quality of evidence was judged as HIGH, MODERATE, LOW or VERY LOW, based on assessment of eight

criteria which can influence our confidence in the results. These criteria are: risk of bias, indirectness,

inconsistency, imprecision, publication bias, large magnitude of effect, dose response and the effect of all

plausible confounding factors for reducing the effect or suggest a spurious effect. Following the quality

assessment, GRADE was then used to indicate the strength of recommendation for each fluoride agent as

STRONG or WEAK/CONDITIONAL. The interpretation of the gradings for quality of evidence and strength of

recommendation are shown in Tables 1 and 2.

Table 1: GRADE ratings and their interpretation

GRADES of

EVIDENCE QUALITY INTERPRETATION

HIGH We are very confident that the true effect lies close to that of the estimate of the

effect.

MODERATE We are moderately confident in the effect estimate: the true effect is likely to be

close to the estimate of the effect, but there is a possibility that it is substantially

different.

LOW Our confidence in the effect estimate is limited: the true effect may be

substantially different from the estimate of the effect.

VERY LOW We have very little confidence in the effect estimate: the true effect is likely to be

substantially different from the estimate of effect.

Table from the GRADE Handbook, available at http://gdt.guidelinedevelopment.org/app/handbook/handbook.html#h.9rdbelsnu4iy

Table 2. Strengths of recommendation for patients, clinicians and policy makers

Strong recommendation Conditional recommendation

For patients

Most people would want the

recommended course of action and

only a small proportion would not

Most people would want the recommended

course of action, but many would not

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For clinicians

Most patients should receive the

recommended course of action

Different choices will be appropriate for different

patients and each patient should be advised for a

management decision consistent with her/his

values and preferences

For policy

makers

The recommendation can be

adopted as a policy in most

situations

Policy making will require substantial debate and

involvement of stakeholders

Adapted from: Guyatt GH, Oxman AD, Kunz R, et al. GRADE Working Group. Rating quality of evidence and

strength of recommendations: going from evidence to recommendations. BMJ.2008; 336:1049–51.

2. Introduction

Fluorides are the key element to successful caries prevention (Marinho, 2009; O’Mullane et al.,2016). They

are also effective as therapeutic agents in non-restorative caries treatment (NRCT) for the inactivation or

arrest of caries lesions (Slayton et al., 2018; Urquhart et al., 2019), but the present EAPD guidelines focus on

their preventive effect only.

Evidence suggests that the cariostatic effect of fluoride is mostly exerted by its topical rather than systemic

effect (Featherstone, 1999). This effect might be even greater when combined with good oral hygiene, such

as when practiced as comprehensive tooth brushing with a fluoride toothpaste (Rolla et al., 1991).

Concern about the prevalence of dental fluorosis in some children has mostly been related to the use of

fluoride supplements, especially during the first 6 years of life (Ismail and Bandekar, 1999). However, it has

also been shown that early exposure to fluoride toothpaste might also be a risk factor due to unintended

ingestion of toothpaste (Levy et al., 1995; Wong et al., 2010 ). Studies that have summarised the risks for

dental fluorosis have concluded that the risk is highest when the exposure takes place in both the secretory

and the maturation phases of enamel formation (Den Besten, 1999; Wong et al., 2010). Therefore, three age

groups can be considered in terms of having a risk for enamel fluorosis, namely:

0-4 years

Babies and children under the age of 4 years are considered to be at risk of dental fluorosis of permanent

incisors and first molars because the calcification and maturation of these teeth occurs during this period of

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life. The longitudinal Iowa study found that exposure to fluoride during the first 3 years of life were most

important for fluorosis development on the permanent maxillary incisors, but other individual periods were

also important (Hong et al., 2006). It is during this period when the use of fluorides must be carefully

monitored and balanced with the need to prevent the occurrence of early childhood caries. Special attention

should be given to the use of topically applied fluorides during this period of life, because of the inadequate

control of the swallowing reflex.

4-6 years

The posterior teeth (premolars and second molars) are calcifying and maturing during this period and at risk

of dental fluorosis. Nevertheless, when this occurs it represents less of an aesthetic problem, which needs

to be weighed against the marked benefit of caries prevention brought about by the use of fluoride.

6 years and above

The risk for enamel fluorosis during this period is negligible, except for third molars.

Use of Silver Diamine Fluoride

Silver diamine fluoride (SDF) at a concentration of 38% (44,800 ppmF) has been rarely used in Europe to

arrest or prevent dental caries, whereas in the Americas, Australasia and Asia it has been frequently used to

arrest dental caries in children (Gao et al., 2019; Tiripathi et al., 2019). The American Academy of Pediatric

Dentistry (AAPD) produced guidelines (Crystal et al., 2017) on the use of SDF for the management of dental

caries in children based on a systematic review of Gao et al., (2016). Per GRADE, this is a CONDITIONAL

recommendation based on low-quality evidence. Interest in the use of SDF in Europe is now growing.

3. Guidelines

The following guidelines are recommended as an integral part of preventive programmes for children. It

must be emphasised, however, that any dentist supervising a child's oral care must address individual needs.

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I. Fluoride Toothpastes

Clinical effectiveness – The widespread use of fluoride toothpastes has most likely been one of the major

reasons for the reduction of dental caries recorded over the past 40 years. Tooth brushing with fluoride

toothpaste is close to an ideal public health method being convenient, inexpensive, culturally approved and

widespread (Burt, 1998). The use of fluoride toothpaste in children and adolescents has been subjected to

several systematic reviews (Marinho et al., 2003; Twetman et al., 2003; Twetman, 2009; Wong et al., 2011;

Wright et al., 2014; Walsh et al., 2019) and all have confirmed its efficacy in preventing caries. The

magnitude, expressed as caries prevented fraction (PF), is summarised in Table 3.

Table 3. Caries-preventive effect of fluoride toothpaste. PF is prevented fraction, expressed as percentage,

with confidence intervals (Marinho, 2009).

Intervention Control PF % (95% CI)

Fluoride toothpaste Placebo 24 (21-28)

Supervised brushing Non-supervised 11 (4-18)

Brushing twice per day Once per day 14 (6-22)

1,450-1,500 ppm F 1,000-1,100 ppm F 8 (1-16)

Fluoride toothpaste + other

sources*

Fluoride toothpaste 10 (2-17)

*Water fluoridation, fluoride varnish, fluoride gel, or fluoride mouth rinsing

Potential harm – One problem with young children’s use of toothpaste is that they swallow some paste with

a subsequent risk of fluorosis (Wong et al., 2011). Fluoride toothpaste may be responsible for up to 80% of

the “optimal” total daily intake of fluoride (Mejare, 2018) and the first 3 years of life seems most critical.

Therefore, parents must be strongly advised to apply an age-related amount of toothpaste and

assist/supervise tooth brushing until at least 7 years of age. To support parents and caregivers to apply the

right amount of toothpaste (grain of rice or pea size), manufacturers, public health institutions and national

societies are encouraged to provide clear visual instructions on toothpaste packaging and in brushing

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instructions. Toothpaste with a lower concentration than 1,000 ppm can be considered for young children

regularly exposed to other sources of fluoride. However, the evidence for these low fluoride concentration

toothpastes of less than 1,000 ppm for the prevention of dental caries is limited (Walsh et al, 2019).

Evidence-based statements – Based on systematic reviews with moderate or low risk of bias, the following

statements can be formulated (Table 4):

Table 4. Statements with quality of evidence and strength of recommendation according to GRADE

Statement GRADE of EVIDENCE

QUALITY

GRADE of RECOMMENDATION

STRENGTH

Daily brushing with fluoride toothpaste

prevents caries

HIGH STRONG

Toothpastes containing higher concentrations

of fluoride are more effective than those with

lower concentration in preventing caries

HIGH STRONG

Supervised tooth brushing is more effective

than non-supervised

HIGH STRONG

There is inconclusive evidence that the use of

fluoridated toothpaste in young children is

associated with an increased risk of fluorosis

LOW CONDITIONAL

Good practice points on brushing behaviour – There are common recommendations on brushing behaviour

that are based on expert opinions and consensus rather than on firm evidence:

Tooth brushing should be conducted so each tooth surface is reached and brushing should exceed one

minute, also in preschool children

Children should avoid rinsing with a lot of water afterwards

Children’s teeth should be brushed using either a soft manual or power toothbrush

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High fluoride toothpaste – Toothpastes with more than 1,500 ppm F are available on prescription in many

countries. Toothpastes containing up to 5,000 ppm F are primarily intended for patients with special care

needs, adolescents with increased caries-risk and those under treatment with fixed orthodontic appliances.

Conclusive evidence for their superior effectiveness is however lacking (Pretty, 2016).

Clinical recommendations

The EAPD recommendations for the use of fluoride toothpastes in children are summarised in Table 5.

Table 5. Recommended use of fluoride toothpastes in children

Age (years) (ppm F) Frequency Amount (gr) Size

First tooth – up to

2 years

1,000 Twice daily 0.125 gram Grain of rice

2-6 years 1,000* Twice daily 0.25 gram Pea

Over 6 years 1,450 Twice daily 0.5-1.0 gram Up to full length

of brush

*For children 2-6 years, 1,000+ fluoride concentrations may be considered based on the individual caries-risk.

The twice daily use of fluoride toothpaste, in combination with oral hygiene instructions, is the cornerstone

of any preventive programme for children, irrespective of caries-risk. Although the caries-preventive effect

is statistically significant only for concentrations of 1,000 ppm and above, toothpastes with lower

concentrations may have some beneficial effects and could be considered for children at low caries-risk

where the risk of fluorosis is of concern (Wong et al., 2011). The evidence of efficacy for outreach supervised

fluoride tooth brushing programmes targeting low socio-economic high-risk groups and ethnic minorities’

remains low (da Silva et al., 2016; Dos Santos et al., 2018). Where fluoride is used in conjunction with other

fluoride vehicles, the cumulative fluoride exposure must be taken into consideration for children less than 6

years of age. Care must be taken to ensure that a balance between maximising the preventive effect against

dental caries and minimising the risk of dental fluorosis is maintained. Furthermore, best available scientific

evidence must be balanced with the expertise of dental professionals and the families’ expectations and

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preferences. The background fluoride exposure as well as the socio-economic level of the community may

also influence the abovementioned recommendations.

Knowledge gaps – According to a map of systematic reviews in paediatric dentistry (Mejàre et al., 2015)

further research is needed on:

the appropriate amount and concentration of fluoride in toothpastes for preschool children related to

the risk of fluorosis.

the effect of toothpaste introduction age, optimal brushing time and post-brushing behaviour on caries

development.

II. Fluoride Gels, Rinses and Varnishes

Apart from the basic caries prevention by the use of fluoridated toothpaste, other topical fluorides can be

used especially in children assessed as being at increased risk for caries development, including children with

special oral health care needs or under orthodontic treatment and in risk periods such as tooth eruption.

The evidence for the caries-preventive effect of gels, rinses and varnishes is greater in quality and quantity

for permanent than primary teeth (Marinho et al. 2013, 2015, 2016; Twetman and Keller 2016). Especially

in preschool children, the risk of ingestion and subsequent dental fluorosis should be weighed against the

potential caries-preventive benefits. Also the cost-effectiveness has to be considered for groups with low

caries prevalence (Schwendicke et al. 2018). This is also true for the mode of application, e. g. with gels,

where in-office application offers greater control, but also higher costs, compared with settings such as

schools or home application with lower costs, but also possibly reduced compliance.

Clinical Recommendations

Available evidence, recommendations and good practice points for fluoride gels, rinses and varnishes in

children and adolescents are shown in Table 6.

Table 6. The evidence, recommendations and good practice points for the use of fluoride gels, rinses and

varnishes in the primary dentition (preschool, 0-5 years of age) and permanent dentition (mixed and young

permanent dentition, 6-18 years of age).

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Modality GRADE of EVIDENCE QUALITY and

RECOMMENDATION STRENGTH

Good Practice Points and

Clinical advice

Gels (professional

use; 5,000-12,300

ppm F)

Primary teeth

EVIDENCE/RECOMMENDATION: NONE

As it is not recommended for preschool

children, there is no grading.

(Effect uncertain. Poulsen, 2009; Marinho

et al., 2015)

Do not use in children < 6 yrs of age, as

risk/benefit ratio is in favour of risk due to

danger of swallowing the gel

Permanent teeth

EVIDENCE: MODERATE

RECOMMENDATION: CONDITIONAL

(Efficacious in preventing caries (Marinho et

al., 2015; Twetman and Keller 2016)

Use 2-4 times per year.

In dental practice remove obvious

deposits of dental plaque and choose

appropriate size trays. Patient should sit in

upright position and not to swallow; use

suction devices during treatment and

after tray removal to minimise

swallowing.

In schools it can be brushed on according

to needs and for home use brush on

weekly.

Instruct child not to eat or drink for 20-30

minutes after application.

Rinses (home or use at

schools);

a) daily: 0.05% NaF

(225ppm F)

b) weekly: 0.2%

NaF (900 ppm F)

Primary teeth

EVIDENCE/RECOMMENDATION: NONE

As it is not recommended for preschool

children, there is no grading.

(No data available. Marinho et al., 2016;

Twetman and Keller 2016)

Do not use in children < 6 yrs of age, as

risk/benefit ratio is in favour of risk, due to

danger of swallowing the rinse.

Permanent teeth

EVIDENCE: MODERATE

RECOMMENDATION: CONDITIONAL

(Efficacious in preventing caries (Marinho et

al., 2016, Twetman and Keller 2016)

Supervised use (by parents or at school)

more efficacious than unsupervised

10 ml of the solution is swished around

the mouth for 1 minute

Instruct child not to eat or drink for 20-30

minutes after application.

Varnishes

(professional

use; typically, 22,600

ppm F)

EVIDENCE: MODERATE

RECOMMENDATION: CONDITIONAL

Should be used for prevention of caries in

both primary and permanent teeth.

Varnish is the only high fluoride topical

agent that can be used in preschool.

Use 2-4 times per year.

Obvious deposits of dental plaque should

be removed prior to application.

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(Efficacious in preventing caries in both

primary and permanent teeth Marinho et

al., 2013)

In order not to exceed the PTD, clinicians

should use a thin film using minimal

amount on caries predilection sites, initial

caries lesions and defects according to

manufacturer´s instructions.

Instruct child not to eat or drink for 20-30

minutes.

III. Fluoridated milk, Fluoridated salt, Fluoride tablets/lozenges and drops

Fluoridated milk

Milk fluoridation has been reported to be successful in dental caries prevention, particularly among children,

and schemes have been developed in countries around the globe based on integration with school health

and nutrition programmes (Jürgensen and Petersen, 2013). Fluoridated milk is only ingested by children on

school days and therefore not at weekends and school holidays. As no effort is required from the individual

for ingesting fluoridated water, salt or milk, these methods have been designated as automatic systems for

dental caries prevention. The use of milk as a vehicle for providing additional fluoride in dental public health

programmes was evaluated in two recent systematic reviews (Cagetti et al., 2013; Yeung et al., 2015).

Cagetti et al (2013) searched literature from 01.01.1966 to 03.31.2011 and found 9 papers of which only two

papers fulfilled their inclusion criteria (Bian et al., 2003; Stecksén-Blicks, 2009). Both these studies

investigated the caries-prevention effect of milk fluoridation on primary teeth. In the first study the GRADE

recommendation strength is CONDITIONAL (Bian et al., 2003), each participant consumed 200 ml of

fluoridated milk (concentration 2.5 mg F- per litre) a day for 21 months. At the end of the experimental

period, the mean net caries increment was 0.4 dmft for the test group and 1.3 dmft for the control group (t-

test, p < 0.001). The second study (Stecksén-Blicks, 2009) evaluated the effect of fluoridated milk on caries

development in pre-school children. Children in the intervention group received 150 ml of milk

supplemented with 2.5 mg of fluoride per litre for lunch, while the control group received standard milk for

21 months. The authors concluded that the daily consumption of milk containing fluoride reduced caries in

pre-school children, with a prevented fraction of 75%. The GRADE strength of recommendation for this study

was also CONDITIONAL. Of the other five studies, only one study (Ketley et al., 2003) failed to demonstrate

the caries preventive effect of milk fluoridation. Four studies suggested that fluoridated milk had a beneficial

effect, reducing caries incidence in both the primary and permanent dentitions. Cagetti et al (2013)

concluded that the consumption of fluoridated milk was an effective measure to prevent caries in primary

teeth but that there was low evidence that the use of milk fluoridation was effective in reducing the caries

increment.

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Yeung et al. (2015) included in a Cochrane review only one unpublished RCT and concluded that there was

low quality evidence to suggest that fluoridated milk may be beneficial to schoolchildren, contributing to a

substantial reduction in dental caries in primary teeth. Due to the low quality of the evidence, further

research is likely to have an important impact on our confidence in the estimate of effect. Furthermore,

there was no information about the potential adverse effects of the intervention. Additional RCTs of high

quality are needed before we can draw definitive conclusions about the benefits of milk fluoridation (Yeung

et al., 2015).

Fluoridated salt

Traditionally, the fluoridation of salt has been considered as an effective method for reducing caries,

especially in areas where water fluoridation cannot be implemented. Two systematic reviews have been

published on the clinical effectiveness of salt fluoridation (Yengopal et al., 2010, Cagetti et al. 2013). In one

of these (Cagetti et al., 2013), no paper related to the use of salt fluoridation in caries prevention fulfilled

the inclusion criteria, and the other one, (Yengopal et al. 2010), concluded that the contribution of

fluoridated salt to the decrease in the prevalence of caries could not be quantified, and further high quality

studies were needed. Wennhall et al., (2014) observed that domestic salt in low caries communities with

vulnerable groups of schoolchildren, did not seem to reduce the number of new caries lesions or to slow

down the progression rate. Take into account that several confounders and bias were identified in this study.

Fabruccini et al., (2016), concluded that in a cross-sectional oral health survey fluoridated water appeared

to provide a better protective effect against caries than fluoridated salt among schoolchildren from

developing countries. However, Jordan et al., (2017) observed that the use of fluoridated salt in a community

feeding programme in an environment with negligible availability of fluoride from other sources resulted in

a considerable caries preventive effect.

Salt fluoridation is suggested (Pollick. 2013; O’Mullane et al. 2016) when water fluoridation cannot be

implemented, but one concern is that promotion of salt consumption for oral health benefits would be

contradictory to the desired reduction of consumption of salt to decrease the risk of hypertension, and the

drawbacks related to variation in ingestion resulting in difficulties in maintaining an ideal concentration.

Fluoride tablets/lozenges and drops

Fluoride tablets/lozenges and drops were first introduced to provide systemic fluoride in areas where water

fluoridation was not available. At the time of introduction, the effectiveness of fluoride toothpaste was not

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yet firmly established. Since the mid 1970’s effective fluoride toothpastes became widely available. In these

years, it was also accepted that the post-eruptive effects of fluorides were sufficiently strong to keep one’s

teeth healthy when properly used (Fejerskov et al., 1981; Fejerskov, 2004). These findings rated fluoride

tablets/lozenges and drops as less meaningful caries preventive measures. Additionally, when using them

care should be taken that the products have sufficient substantivity in the oral cavity to also exert a topical

effect.

In 2009 the EAPD concluded that at that time there was a lack of evidence to make good recommendations

(Swedish Council on Technology Assessment in Health Care, 2002; Espelid, 2008). The EAPD also advised to

monitor the total daily amount of fluoride ingersted which should not exceed 0.07mg/kg bodyweight daily

(Fejerskov et al, 1977).

Since the previous position paper of the EAPD (2009) no new RCT’s examining the effect of fluoride

tablets/lozenges or drops have been published. Two systematic reviews both concluded that there might

be an effect for the permanent dentition but that there was no clarity on the effect for the primary dentition

(Tubert-Jeanin et al. 2011; Tomasin et al., 2015). It has to be noted that both reviews examined older studies,

conducted at a time when topical fluorides were not widely used and that were also available when the

previous position paper of the EAPD (2009) was compiled.

One Cochrane review, examining whether it was beneficial for pregnant women to use fluoride supplements

to prevent future dental caries in their offspring found no evidence to support this (Takahashi et al., 2017).

Recommendation

Fluoridated milk and fluoridated salt could be part of community health programmes in target groups with

high caries prevalence and low compliance for tooth brushing with fluoridated toothpaste in areas without

water fluoridation (GRADE of recommendation: CONDITIONAL). Fluoride tablets/lozenges and drops could

be considered on an individual basis for children at high risk for caries (GRADE of recommendation:

CONDITIONAL), but improving the quality of tooth brushing or using a higher concentration of fluoridated

toothpaste would be the first option.

IV. Water Fluoridation

Water fluoridation

In the 21st century, dental caries remains a global health problem. It is estimated that 573 million children

worldwide have untreated dental caries in their primary teeth, while untreated caries in permanent teeth

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affects 2.5 billion people (Kassebaum et al., 2017). Community water fluoridation (CWF) is the process of

adjusting the amount of fluoride found in water to achieve optimal prevention of dental caries (Centers for

Disease Control and Prevention, 2016). The fluoride concentration of water in CWF programmes typically

ranges from 0.5 to 1.1 mg/L.

CWF was introduced over 70 years ago as a public health measure to prevent and control caries at a

population level, and in many countries throughout the world, CWF remains a core component of oral health

policy. In 2012, the worldwide total of people supplied with artificially fluoridated water was estimated at

approximately 370 million (British Fluoridation Society, 2012).

The great advantage of CWF is that it benefits all residents in a community, regardless of age, socio-

economic status, education, oral hygiene practices, employment or access to routine dental care, making it

a truly equitable public health practice (Buzalaf et al., 2011; Public Health Agency of Canada, 2016). CWF is

also a cost-effective method of delivering caries prevention to a large population, and the larger the

community served, the greater the cost saving (Ran and Chattopadhyay, 2016).

The effectiveness of CWF at preventing dental caries has been extensively and regularly investigated since

the middle of the 20th century. A recent Cochrane review estimated that the initiation of CWF reduced

caries levels by 35% in the primary dentition and 26% in the permanent dentition of children. The review

also found that CWF led to a 15% increase in the percentage of children with caries-free primary teeth and

a 14% increase in the percentage of children with caries-free permanent dentitions, compared to children

without water fluoridation (Iheozor-Ejiofor et al., 2015). The reviewers questioned the applicability of these

results to current lifestyles, as most of the included studies were conducted before the widespread use of

fluoride toothpaste. The inclusion criteria of the Cochrane review, which focused on the initiation of CWF,

meant that the large body of contemporary data on CWF was excluded. Contemporary studies of the

effectiveness of water CWF are primarily cross-sectional surveillance surveys in populations with established

CWF programmes, where the use of fluoride toothpaste is ubiquitous. Reviews of such contemporary

studies have reported substantial caries reductions in both children and adults who reside in fluoridated

areas, compared to those in non-fluoridated areas (Griffin et al., 2007; Rugg-Gunn and Do, 2012). A

Cochrane review of the effectiveness of fluoride toothpaste also found an additional caries-preventive

benefit when F toothpaste was used in areas with fluoridated water (Marinho et al., 2003).

Since its introduction in the mid-20th century, concerns have been expressed about the possible health

effects of CWF. Several recent comprehensive reviews on the impact of fluoridated water on human health

have been published (Scientific Committee on Health and Environmental Risks (SCHER), 2011; Royal Society

of New Zealand & Office of the Prime Minister's Chief Scientific Advisor, 2014, Sutton et al., 2015, National

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Health and Medical Research Council (NHMRC), 2016). No reliable evidence for any adverse health effects

associated with the use of fluoridated water at the low levels used in CWF were found by any of these

reviews. One review also considered the environmental impact of artificially fluoridated water and

concluded that exposure of environmental organisms to the levels of fluoride used for fluoridation of

drinking water was not expected to lead to unacceptable risks to the environment (Scientific Committee on

Health and Environmental Risks (SCHER), 2011).

Dental Fluorosis at the lower levels (Dean’s Index) is the only unwanted effect that is definitively associated

with CWF. The Cochrane review of water fluoridation estimated a prevalence of 12% for fluorosis of aesthetic

concern at water fluoride levels of 0.7mg/L (Iheozor-Ejiofor et al., 2015).

Bottled drinking water is extensively used in many countries, including those with CWF, where it may

displace the consumption of fluoridated tap water. Bottled water, if optimally fluoridated, could offer an

additional option for population caries prevention. However, further research on the role of fluoride-

containing bottled waters, dental caries and fluorosis is needed.

Recommendation

The EAPD reaffirms its support for the use of community water fluoridation as a safe, effective, relevant and

cost-saving public health measure for the prevention and control of dental caries. The Academy recognises

that CWF alone is not a panacea but should be seen as an important element in a multi-faceted approach to

caries prevention and control, which includes oral health promotion and access to affordable care.

The Academy recognises the need for ongoing population surveillance of the dental and health effects of

fluoridated water to assure its continued safety, effectiveness and relevance.

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Acknowledgements The European Academy of Paediatric Dentistry wishes to thank Professor Jack Toumba and Dr Nick A. Lygidakis (Workshop and Report Coordinators), for organising the Fluoride Workshop in Athens, Greece, November 16-17, 2018, that has enabled the updating of the EAPD Fluoride Guidelines. Special thanks should be attributed to those who took part in the Workshop and to the speakers in the scientific sessions, who all contributed their valuable knowledge leading to the development of these guidelines. Workshop groups moderators and participants: Fluoride Toothpaste: Moderator: Svante Twetman (Denmark). Participants: Dominique Declerck (Belgium), Norbert Kramer (Germany), Nick Lygidakis (Greece), Ulrich Schiffner (Germany), Jack Toumba (UK). Fluoride Gels, Rinses and Varnishes: Moderator: Christian Splieth (Germany). Participants: Sotiria Gizani (Greece), Rita Cauwels (Belgium), William Papaioannou (Greece) . Fluoridated milk and salt, Fluoride tablets/lozenges and drops: Moderator: Cor van Loveren (The Netherlands). Participants: Elias Berdouses (Greece), Olga Cortes (Spain), Betul Kargul (Turkey), Katerina Kavvadia (Greece). Water Fluoridation: Moderator: Carmel Parnell (Ireland). Participants: Mairead Harding (Ireland), Vassiliki Topitsoglou (Greece). Fluorides and erosion: Adrian Lussi (Switzerland)

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